Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
metformin hydrochloride, Quantity: 850 mg; sitagliptin phosphate monohydrate, Quantity: 64.25 mg (Equivalent: sitagliptin, Qty 50 mg)
Merck Sharp & Dohme (Australia) Pty Ltd
Metformin hydrochloride,sitagliptin phosphate monohydrate
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; sodium stearylfumarate; povidone; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black
Oral
56 tablets, 14 tablets (starter pack)
(S4) Prescription Only Medicine
VELMETIA (sitagliptin phosphate monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.,[see Sections 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials and 4.2 DOSE AND METHOD OF ADMINISTRATION].
Visual Identification: Pink, film coated tablet with "515" on one side and plain on the other.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2014-11-19
VELMETIA ® V E L M E T I A ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING VELMETIA? VELMETIA contains the active ingredients sitagliptin (as phosphate monohydrate) and metformin (as hydrochloride). VELMETIA is used to lower blood sugar levels in adults with diabetes mellitus. For more information, see Section 1. Why am I taking VELMETIA? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE VELMETIA? Do not take if you have ever had an allergic reaction to VELMETIA or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I take VELMETIA? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with VELMETIA and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I TAKE VELMETIA? • Your doctor will tell you how many VELMETIA tablets to take and how often to take them. • Take VELMETIA with meals to lower your chance of an upset stomach. More instructions can be found in Section 4. How do I take VELMETIA? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING VELMETIA? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using VELMETIA. • Call your doctor straight away if you if you become pregnant while taking VELMETIA. THINGS YOU SHOULD NOT DO • Do not stop taking this medicine suddenly. • Do not give VELMETIA to anyone else, even if they have the same condition as you. DRIVING OR USING MACHINES • There is no information to suggest that VELMETIA affects your ability to drive a car or operate machinery. DRINKING ALCOHOL • Tell your doctor if you drink alcohol. LOOKING AFTER YOUR MEDICINE • Keep your tablets Lees het volledige document
1 AUSTRALIAN PRODUCT INFORMATION – VELMETIA ® (SITAGLIPTIN PHOSPHATE MONOHYDRATE/METFORMIN HYDROCHLORIDE) 50 MG/500 MG, 50 MG/850 MG & 50 MG/1000 MG VELMETIA ® XR (SITAGLIPTIN PHOSPHATE MONOHYDRATE/METFORMIN HYDROCHLORIDE MODIFIED RELEASE) 50 MG/500 MG, 50 MG/1000 MG & 100 MG/1000 MG 1 NAME OF THE MEDICINE sitagliptin phosphate monohydrate/metformin hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION VELMETIA and VELMETIA XR both contain sitagliptin phosphate and metformin hydrochloride. VELMETIA tablets consist of sitagliptin and an immediate-release formulation of metformin, and VELMETIA XR tablets consist of sitagliptin and a modified release formulation of metformin. VELMETIA is available for oral administration as film-coated tablets containing sitagliptin phosphate monohydrate and metformin hydrochloride equivalent to: 50 mg sitagliptin as free base and 500 mg metformin hydrochloride (VELMETIA 50 mg/500 mg), 850 mg metformin hydrochloride (VELMETIA 50 mg/850 mg) or 1000 mg metformin hydrochloride (VELMETIA 50 mg/1000 mg). VELMETIA XR is available for oral administration as film-coated tablets containing sitagliptin phosphate monohydrate equivalent to 50 mg sitagliptin as free base and either 500 mg metformin hydrochloride modified release (VELMETIA XR 50 mg/500 mg*), or 1000 mg metformin hydrochloride modified release (VELMETIA XR 50 mg/1000 mg). Additionally, VELMETIA XR is available for oral administration as tablets containing sitagliptin phosphate monohydrate equivalent to 100 mg sitagliptin as free base and 1000 mg metformin hydrochloride modified release (VELMETIA XR 100 mg/1000 mg). For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM VELMETIA 50 mg/500 mg - a light pink, film coated tablet with "575" on one side and plain on the other. VELMETIA 50 mg/850 mg - a pink, film coated tablet with "515" on one side and plain on the other. VELMETIA 50 mg/1000 mg - a red, film coated tablet with "577" on one side and plain on the other. VELMETIA XR consists of a Lees het volledige document